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Nanoemulsions Containing Megestrol Acetate: Development, Characterization, and Stability Evaluation

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Abstract

Many active pharmaceutical ingredients (API) are poorly soluble in water and their low oral bioavailability is a major hindrance to their potential use. Megestrol acetate (MGA) is insoluble in water and its oral absorption is limited and considerably affected by food. Nanoemulsions (NEs) can be used as effective oral drug delivery systems where the hydrophobic API is loaded into the oil phase. In this study, MGA-loaded NEs were prepared based on the spontaneous emulsification technique. The effects of different excipients such as ethanol, Tween 80, Lipoid E80, and medium-chain triglyceride (MCT) on the NEs characterization were investigated. The experimental results indicated that optimum MGA-loaded NEs (F20) were nanometer-sized droplets (166.9 ± 3.0 nm) with negative zeta potential (−12.2 ± 1.1 mV). The effect of polyvinylpyrrolidone (PVP) on characteristic properties of F20 was also evaluated. On the selected NEs, in vitro dissolution tests and stability studies in various mediums and storage conditions were performed. The encapsulation efficiency of NEs were > 99%. The overall droplet size of F20 and PVP-2 (PVP-coated NEs) remained relatively stable as the pH changed from 1.2 to 6.8. It was determined that F20 and PVP-2 remained stable at 4°C until 12 weeks and had higher cytotoxicity on MCF-7 cells. To conclude, droplet size, surface charge, and stability are important properties for NEs to have sufficient effectiveness. In this study, alternative oral NEs of low-solubility drug MGA were developed considering the above features.

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Acknowledgements

The authors want to thank Deva Holding AS for supplying MGA and Lipoid GmbH for supplying egg lecithin (Lipoid E80). The authors are also grateful to Prof. Didem DELIORMAN ORHAN and Prof. Esra KUPELI AKKOL (Gazi University Faculty of Pharmacy, Department of Pharmacognosy) for providing some facilities to carry out this research.

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  1. Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, 06330, Yenimahalle, Ankara, Turkey

    Tahir Emre Yalcin, Emre Tuncel & Figen Tirnaksiz

  2. Department of Pharmaceutical Technology, Faculty of Pharmacy, Erciyes University, 38280, Talas, Kayseri, Turkey

    Cigdem Yucel

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  2. Emre Tuncel
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  3. Cigdem Yucel
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  4. Figen Tirnaksiz
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Contributions

Tahir E. Yalcin: conceptualization, investigation, methodology, formal analysis, writing—original draft. Emre Tuncel: conceptualization, investigation, methodology, formal analysis, writing—original draft. Cigdem Yucel: conceptualization, investigation, methodology, formal analysis, writing—original draft of cytotoxicity section. Figen Tirnaksiz: conceptualization, methodology, supervision, writing—review and editing.

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Correspondence to Tahir Emre Yalcin.

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Yalcin, T.E., Tuncel, E., Yucel, C. et al. Nanoemulsions Containing Megestrol Acetate: Development, Characterization, and Stability Evaluation. AAPS PharmSciTech 23, 142 (2022). https://doi.org/10.1208/s12249-022-02289-7

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  • DOI: https://doi.org/10.1208/s12249-022-02289-7

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